Flexible anchor delivery system

ABSTRACT

An assembly includes a flexible fixation member, a suture, and a delivery device. The fixation member includes a body with two terminal ends. A suture passes through the flexible fixation member at various points along a length of the body such that portions of the fixation member are slidable relative to the suture and configurable to form a cluster within a surgical site. The delivery device includes a tubular member, an elongated inserter, and a trigger. The elongated inserter is slidably disposed within the tubular member. The inserter has a forked distal end configured to receive a portion of the flexible fixation member and the suture. The trigger is finger-engagable and fixedly coupled to the proximal end of the inserter. It is configured to advance and retract the inserter relative to the tubular member. The trigger includes a retention member for retaining a proximal end portion of the suture.

TECHNICAL FIELD

This disclosure relates to apparatus and methods for repairing tissue.

BACKGROUND

Arthroscopic procedures using sutures and suture anchors have been usedin tissue repair to, for example, secure soft tissue to bone. Theseanchors may not fully deploy below the cortical layer. An anchor that isnot fully deployed at the time of installation does not provide maximumfixation and could migrate later causing the repair suture to loosen,sacrificing the integrity of the repair. An anchor not providing itsmaximum fixation may result in pull out during or after the repairprocedure. Anchors may also be damaged during insertion. Fraying of theanchor and repair sutures, or other damage, may result in a number ofproblems including compromised anchor construct, anchor severing, repairsuture severing, the repair suture pulling through the anchor, etc.

SUMMARY

The details of one or more implementations of the disclosure are setforth in the accompanying drawings and the description below. Otherfeatures and advantages will be apparent from the description anddrawings, and from the claims.

In one aspect, an assembly includes a flexible fixation member, asuture, and a delivery device. The flexible fixation member includes abody with two terminal ends. A suture passes through the flexiblefixation member at various points along a length of the body between theterminal ends such that portions of the fixation member are slidablerelative to the suture and configurable to form a cluster within asurgical site. The delivery device includes a tubular member, anelongated inserter, and a trigger. The elongated inserter is slidablydisposed within the tubular member. The inserter has a forked distal endand a proximal end, the forked distal end is configured to receive aportion of the flexible fixation member and the suture. The trigger isfinger-engagable and is fixedly coupled to the proximal end of theinserter. It is configured to advance and retract the inserter relativeto the tubular member. The trigger includes a retention member forretaining a proximal end portion of the suture.

Implementations may include one or more of the following. For example,the delivery device may further include a handle to which the trigger isslidably coupled. The delivery device may further include a buttoncoupled to the trigger and the handle and configured to permit thetrigger to slide relative to the handle when the button is depressed.The handle may define a plurality of cutout portions along a length ofthe handle. The cutout portions are configured to receive a portion ofthe button therein to fixedly engage the trigger to the handle. Thetrigger may further include a circumferential groove defined about aperiphery of the trigger. A length of the suture may be wrapped abouttrigger at least once and retained in the groove. The trigger may definea slot configured to receive a portion of the suture therethrough anddirect the suture into the groove. The trigger may have a substantiallycylindrical body and a pair of finger-engagable elements extendinglaterally from the body. The delivery device may also include a coverdisposed over the retention member. The handle may define two openingsin a distal end of the handle, a first opening positioned distally withrespect to a second opening, such that the suture passes from aninterior to an exterior of the handle through the first of the twoopenings and the suture passes from the exterior to the interior of thehandle through the second of the two openings. The handle may define twoopenings in a distal end of the handle, a first opening positioneddistally with respect to a second opening, such that the suture passesfrom an interior to an exterior of the handle through the second of thetwo openings and the suture passes from the exterior to the interior ofthe handle through the first of the two openings. The handle may definean opening in a distal end of the handle, such that the suture passesfrom an interior to an exterior of the handle through the opening. Thedelivery device may further include a cover element releasably coupledto a distal end of the handle and fixed coupled to a proximal end of thetubular member. The suture may pass through the fixation member to formtwo substantially parallel tail sections of suture. The fixation membermay be non-tubular. The flexible fixation member and the suture maycomprise a size 2 suture.

In another aspect, a method of closing a tissue wound, includesdelivering a wound closure assembly to a surgical site, advancing aninserter distally relative to a tubular member to position the flexiblefixation member within a targeted tissue site, tensioning a suture toform a cluster of the portions of the fixation member within thesurgical site, and retracting the inserter proximally relative to thetubular member to remove the forked distal end of the inserter fromwithin the targeted tissue site. The wound closure assembly including aflexible fixation member, a suture, and a delivery device. The flexiblefixation member includes a body having two terminal ends. The suturepasses through the flexible fixation member at various points along alength of the body between the terminal ends such that portions of thefixation member are slidable relative to the suture and configurable toform a cluster within a surgical site. The delivery device has a tubularmember, an elongated inserter slidably disposed within the tubularmember, and a finger-engagable trigger. The inserter has a forked distalend, configured to receive a portion of the flexible fixation member andthe suture therein. The finger-engagable trigger is fixedly coupled tothe proximal end of the inserter and configured to advance and retractthe inserter relative to the tubular member. The trigger comprises aretention member for retaining a proximal end portion of the suture.

Implementations may include one or more of the following. For example,tensioning the suture to form the cluster of the portions of thefixation member with the surgical site may include pulling the fixationmember against a distal end of the tubular member. Tensioning the suturemay be carried out by moving the trigger in a proximal directionrelative to the tubular member. Retracting the inserter may be carriedout by moving the trigger in a proximal direction relative to thetubular member. Tensioning the suture and retracting the inserter arecarried out by moving the trigger in a proximal direction relative tothe tubular member such that the forked end of the inserter is movedproximally over a distance before tensioning of the suture begins. Themethod may further include drilling a hole into the tissue.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a delivery device.

FIG. 2 is a perspective view of a proximal portion of the deliverydevice of FIG. 1.

FIGS. 3A and 3B are perspective views of a handle of the delivery deviceof FIG. 1.

FIGS. 4B-4D are perspective views of a partial assembly of the proximalportion of the delivery device of FIG. 1 including the trigger of FIG.4A.

FIG. 4E is a cutaway view of a partial assembly of the proximal portionof the delivery device of FIG. 1.

FIGS. 4F-4H are cutaway views of embodiments of the delivery device ofFIG. 1 with different suture routing pathways within the handle;

FIGS. 5A and 5B are perspective views of a partial assembly of theproximal portion of the delivery device of FIG. 1 including a coverelement and tubular member.

FIG. 6 is a cutaway view of the proximal portion of the delivery deviceof FIG. 1.

FIGS. 7-9 are perspective views of the distal end of the delivery deviceof FIG. 1.

FIG. 10 is a plan view of a flexible fixation member and sutureassembly.

FIGS. 11A-11C illustrate the method of use of the proximal end of adelivery device.

FIGS. 12A-12C illustrate the method of use of the distal end of adelivery device with the flexible fixation member and suture assembly ofFIG. 10.

FIG. 13A is a plan view of a flexible fixation member and sutureassembly.

FIGS. 13B-13E illustrate the method of use of the distal end of adelivery device with the flexible fixation member and suture assembly ofFIG. 13 a.

FIGS. 14A-14D illustrate the method of use of the distal end of adelivery device with another flexible fixation member and sutureassembly.

FIGS. 15A-15C illustrate the method of use of the distal end of adelivery device with another flexible fixation member and sutureassembly

FIGS. 16A-16F are perspective views of an angled guide.

FIGS. 17A-17E are perspective views of a flexible delivery device.

FIG. 18A is a plan view of a flexible delivery device with a suturerouted externally.

FIG. 18B is a plan view of a flexible delivery device with a suturerouted internally.

FIGS. 19A-19C are plan views of angled guides and a flexible drill orinserter.

FIG. 20A is a perspective view of the distal end of an angled guide andflexible inserter.

FIG. 20B is a perspective view of the distal end of an angled guide andflexible drill.

FIG. 20C is a perspective view the distal end of an angled swaged guideand flexible inserter.

FIG. 20D is a perspective view of the distal end of an angled guide andflexible drill.

DETAILED DESCRIPTION

FIG. 1 shows a surgical device 100 used for delivering one or morefixation members to a surgical site. The device 100 includes a handle128, a trigger 116 movable coupled to the handle 128, a cover element114 coupled to the trigger 116, a tubular member 110 attached to thecover element 114, and fixation member or anchor 102 having a flexiblemember or suture 104 (FIG. 8) interwoven through the fixation member102. The fixation member 102 and suture 104 are disposed in a distal end106 of an elongated inserter 108 (FIG. 8). The elongated inserter 108 isslidably positioned within the tubular member 110. The proximal end 112of tubular member 110 is coupled to the cover element 114. The proximalend of the delivery device 100 is shown in more detail in FIG. 2. Thecover element 114 is coupled to a cover 126 and the trigger 116. Thetrigger 116 includes a body 118, finger engagable elements 120 extendinggenerally perpendicular from a longitudinal axis of the body 118, acircumferential groove 122, and a button 124. The trigger 116 is movablycoupled to the handle 128. The button 124 interacts with cutout portions130 (FIG. 3) in the handle 128 to lock the motion of the trigger 116with respect to the handle 128. The button 124 can be depressed, whicheliminates the interference between the button 124 and the cutouts 130allowing motion of the trigger 116 with respect to the handle 128.

Referring to FIGS. 3A and 3B, the handle 128 includes an enlargedproximal end 132 that may enhance a user's grip on the handle 128. Theproximal end 132 is connected to or formed integral with a hollowelongated body 134. The body 134 includes a longitudinal slot 136extending from a distal end 138 at least partially toward the proximalend 132. One of the enlarged proximal end 132 or the proximal wall 137of the slot 136 may act as a stop for the trigger 116. Distal end 138also includes two straight portions 139 a and 139 b. Cut out portions130 are provided along the slot 136 and are sized to receive a portionof the button 124. The distal end 138 includes mating features 140 tocouple with the cover element 114. The proximal end 133 of the body 134includes a protrusion 141 which interacts with the trigger 116 to act asa detent for the trigger 116 in the deployed orientation. Theinteraction of protrusions 141 and the trigger 116 may also create anaudible click or sound. Groove 142 and openings 144 a, 144 b in thedistal end 138 of the handle 128 allow for routing of the suture 104 aswill be explained in more detail below.

The trigger 116, shown in FIG. 4A, includes two finger engagableelements 120 protruding from either side of the body 118. The fingerengagable elements 120 are designed to be grasped by a surgeon's fingerswhile the device is being operated, as described in more detail below.Slots 146 and 148 extend from the distal end 150 of the trigger 116 andmay be in contact with the groove 122. The slot 148 and the groove 122are designed for routing of the suture 104 as shown. The groove 122 runscircumferentially around the trigger's body 118 and allows for longersutures to be wrapped around it, increasing the length of suture thatcan be used with the delivery device 100. Trigger 116 also includes aretention member 152 with a slot 153 which is used to cleat sutures 104to keep them in place. Button 124 fits in a rectangular cutout 125 inthe proximal end 154 of the trigger 116. In its upright position, thebutton 124 engages cutout portions 130 of the handle 128 (FIG. 3A) andprevents the trigger 116 from moving with respect to the handle 128.When the button 124 is depressed, the trigger 116 is free to slide upand down the body 134 of the handle 128.

FIGS. 4B-4E show the trigger 116, handle, 128, and elongated inserter108 in an assembled configuration. The elongated inserter 108 isattached to a tongue 156 of the trigger 116 by, for example, insertmolding, friction fit, welding or some other suitable attachment means,such that the elongated inserter 108 moves with the trigger 116. Theproximal end of the elongated inserter 108 has reliefs 172 (FIG. 6) toprevent the inserter 108 from pushing through the tongue 156 in thetrigger 116. The tongue 156 of the trigger 116 fits through the slot 136and within the hollow portion of the body 134 of the handle 128, whilethe body 118 of the trigger 116 is slidingly coupled to the body 134 ofthe handle 128. The mating features 158 of the button 124 may engage thecutout portions 130 of the handle 128, when the button is in its uprightposition (FIG. 4E) to prevent the trigger 116 from moving with respectto the handle 128. The trigger 116 may be injection molded and made ofABS. The trigger 116 and the handle 128 are made of dissimilar materialsto reduce the friction between the two which allows the trigger to slidealong the body 134 of the handle more easily.

As shown in FIGS. 4A, 4D, and 4F, the suture 104 travels down theelongated inserter 108, is routed out of the handle 128 through hole 144a, and then back through hole 144 b before passing out of slot 148 andwrapping around trigger 116. Some slack is left in the suture 104. Theends of the suture 104 can be secured in the slot 153 on the retentionmember 152.

In alternative embodiments, the tension within the suture 104 may bevaried by changing the routing path of the suture 104 within the handle128. As discussed in greater detail below, the ability to variablytension the suture 104 may facilitate fixation of the flexible fixationmember 102 in bone. For example, decreasing the path length of thesuture 104, as compared to the routing path illustrated in FIGS. 4A, 4D,and 4F, may increase the tension of the suture 104.

FIG. 4G illustrates one embodiment of a suture routing path whichincreases the suture tension, as compared to the routing path of FIGS.4A, 4D, and 4F. The suture 104 travels down the elongated inserter 108and is routed out of the handle 128 through hole 144 b and then backthrough hole 144 a before passing out of the slot 148 and wrappingaround trigger 116. Less slack is left in the suture 104, as compared tosuture routing path illustrated FIGS. 4A, 4D, and 4F. The ends of thesuture 104 can be secured in the slot 153 on the retention member 152.

FIG. 4H illustrates another embodiment of a suture routing path whichfurther increases the suture tension, as compared to the routing path ofFIG. 4G. In contrast to the embodiments above, the suture 104 is notrouted out of the handle 128 through either hole 144 b or hole 144 abefore passing out of the slot 148. Instead, the suture 104 travels downthe elongated inserter 108, passes out of the slot 148, and wraps aroundtrigger 116. Relatively little slack is left in the suture 104, ascompared to the routing pathways of FIG. 4A, 4D, 4F, or 4G. The ends ofthe suture 104 can be secured in the slot 153 on the retention member152.

Referring to FIGS. 5A and 5B, the cover element 114 is coupled to thetubular member 110 by; for example, insert molding, welding, frictionfit, or other suitable means. The cover element 114 also includes matingfeatures 162 to engage mating features 140 of the handle 128 (FIGS. 3Aand 3B), and mating feature 160 to engage the cover 126 (FIG. 1). Ahollow cavity 164 extends from the proximal end 166 of the cover element114 towards its distal end 167. The hollow cavity 164 has two straightportions 168 a, 168 b which engage straight portions 139 a, 139 b of thehandle 128 and allow the handle 128 and cover element 114 to rotatetogether, but limit the handle 128 and cover element 114 from rotatingrelative to each other. The edges of the hollow cavity 164 have achamfer 169 to provide lead-in for ease of assembly.

FIG. 6 is a cutaway view of the proximal end of the delivery device 100.The trigger 116 is shown pulled back towards the end of the proximal end133 of the body 134 of the handle 128. This is considered the “fullydeployed” position, as described below. When the trigger 116 reaches thefully deployed position the protrusions 170 of the trigger 116 areforced over the protrusions 141 of the handle 128. This may produce anaudible snap, allowing the surgeon to easily recognize when the deliverydevice 100 has reached its fully deployed state.

FIGS. 7-9 show the distal end of the delivery device 100. Suture 104 isthreaded through a flexible fixation member 102 bent in a generalu-shape and having two terminal ends 103 a, 103 b (FIG. 10). Theflexible fixation member 102 is formed of a malleable or flexible body.The suture 104 includes two terminal ends (not shown). One of theterminal ends is passed through the flexible fixation member 102 formingmultiple curved portions of the suture 104. The suture 104 may slidewith respect to the flexible fixation member 102 to form a cluster orbunch 30 including a number of folds as shown in FIG. 12C. The bunch 30may be used to secure tissue within a surgical site as will be describedin more detail below.

Portions of the suture 104 and flexible fixation member 102 are seatedin a forked distal end 106 of the elongated inserter 108. The elongatedinserter 108 is rectangular in cross-section but could be any types ofshapes, including circular, hexagonal, triangular, polygonal, or othersuitable shape. The flat sides of the elongated inserter 108 allow thesuture to pass through the smaller distal end 111 of the tubular member110 with the elongated inserter 108 without being pinched or compressed.The elongated inserter 108 transitions from a rectangular profile at thedistal end 106 to a circular profile at the proximal end and mates withthe tongue 156 of the trigger 116, as illustrated in FIG. 8.

FIGS. 11A-11C and 12A-12C illustrate a method of using the deliverydevice 100 of FIG. 1 to deploy a flexible fixation member 102 to below acortical layer 204. FIG. 11A shows a delivery device 100 which is readyfor use. The delivery device 100 is loaded with a flexible fixationmember 102 and suture 104 assembly (FIG. 10). The suture 104 is routedthrough the tubular member 110 and through the delivery device 100 asdescribed above, and then secured in retention member 152. The cover 126hides the suture 104 that is secured in the retention member 152 toprevent premature uncleating of the suture 104, for example, by a userpulling the suture 104 loose from the retention member 152. Referring toFIGS. 12A-12C, a hole 202 is drilled through the cortical layer 204 andinto the cancellous layer 206 of bone using a drill guide 208. Thedistal end of the delivery device 100 is inserted into the drill guide(FIG. 12A). As the distal end of the delivery device 100 is advancedthrough the drill guide 208, the forked distal end 106 of the elongatedinserter 108 moves the flexible fixation member 102 and suture 104assembly past the cortical layer of bone 204 and into the cancellouslayer 206 until the distal end 111 of the tubular member 110 isgenerally aligned with or past the bottom of the cortical layer 204, asshown in FIG. 12B. The button 124 is then depressed to allow the trigger116 to be pulled towards the proximal end 132 of the handle 128 (FIG.11B), pulling the elongated inserter 108 and the suture 104 back. As thetrigger 116 is moved toward the proximal end 132 of the handle 128, theretention member 152 and the suture 104 secured therein becomeaccessible.

As the trigger 116 is retracted, the elongated inserter 108 is drawn upinto the tubular member 110, slack in the suture 104 is taken up, andthe suture 104 is tensioned. The flexible fixation member 102 is largerthan the distal tip 111 of the tubular member 110. As the elongatedinserter 108 and the suture 104 are drawn back, the flexible fixationmember 102 begins to bunch against the distal edge 111 of the tubularmember 110. When the trigger 116 is fully retracted, the flexiblefixation member 102 is bunched such that it will not pull out of thehole 202 drilled in the bone. The suture 104 can then be uncleated fromthe retention member 152.

The level of tension of the suture 104 may also be adjusted, prior toretraction of the trigger 116, to facilitate retention of the flexiblefixation member 102 in the bone. In general, the flexible fixationmember 102 exerts a hoop stress upon the bone surrounding the hole 202,displacing the adjacent bone and retaining the flexible fixation member102 in place. As the density of the bone increases, however, the degreeto which the flexible fixation member 102 displaces adjacent bone maydecrease for a given hoop stress. In turn, the degree to which theflexible fixation member 102 is secured within the bone may decrease. Byincreasing the level of tension within the suture 104 prior toretraction of the trigger 116 (e.g., by suture routing as illustratedabove in FIGS. 4F-4H), the hoop stress exerted by the flexible fixationmember 102 may be increased. Accordingly, when employing the surgicaldevice 100 to deposit a flexible fixation member 102 in relatively densebone, it may be desirable to increase the level of tension within thesuture 104 prior to retraction of the trigger 116.

FIG. 13A is an alternative implementation of weaving the suture 304through the flexible fixation member 302. In this implementation, theflexible fixation member 302 is not bent into au-shape, but issubstantially straight while both ends of the suture 304 are inserted inand out of the flexible fixation member 302. This implementation alsoincludes an outer tubular member 306 which is inserted through thecortical layer 308 and into the cancellous layer 310 with the flexiblefixation member 302 and suture 304 assembly. This outer tubular member306 provides additional protection for the flexible fixation member 302and suture 304, and prevents any pinching or other damage to theflexible fixation member 302 or suture 304 during insertion.

The method of delivery is similar to the method described above. Thesuture 304 is routed through the tubular member 312 and through thedelivery device 100 as described above, and then secured in retentionmember 152. The cover 126 hides the suture 304 that is secured in theretention member 152 to prevent premature uncleating of the suture 304.A hole 316 is drilled through the cortical layer 308 and into thecancellous layer 310 of bone using a drill guide 318. The distal end ofthe delivery device 100 is inserted into the drill guide 318 (FIG. 13B).The distal end of the delivery device 100 is advanced through the drillguide 318 until the outer tubular member 306 is past the cortical layerof bone 308 and into the cancellous layer 310 and the distal edge 314 ofthe tubular member 312 is generally aligned with or past the bottom ofthe cortical layer 308, as shown in FIG. 13C. The button 124 is thendepressed to allow the trigger 116 to be pulled towards the proximal end132 of the handle 128, as shown in FIG. 11B, pulling the outer tubularmember 306 and the suture 304 back. As the trigger 116 is moved towardthe proximal end 132 of the handle 128, the retention member 152 and thesuture 304 secured therein become accessible. The flexible fixationmember 302 is larger than the distal tip 314 of the tubular member 312.As the outer tubular member 306 and the suture 304 are drawn back, theflexible fixation member 302 begins to bunch against the distal edge 314of the tubular member 312. When the trigger 116 is fully retracted, theflexible fixation member 302 is bunched such that it will not pull outof the hole 316 drilled in the bone. The suture can then be uncleatedfrom the retention member 152.

FIGS. 14A-14D show another implementation of the flexible fixationmember 402 and suture 404. In this implementation, the flexible fixationmember 402 is straight while one end 405 a of the suture 404 is insertedin and out of the flexible fixation member 402 and one end 405 b of thesuture 404 runs parallel to the straight fixation member 402.

The method of delivery is the same method as described above withrespect to FIGS. 13B-13E. The suture 404 is routed through a tubularmember 420, through the delivery device 100, and secured in retentionmember 152. The cover 126 hides the suture 404 that is secured in theretention member 152. A hole 422 is drilled through the cortical layer424 and into the cancellous layer 426 of bone using a drill guide 428.The distal end of the delivery device 100 is inserted into the drillguide (FIG. 14A). The distal end of the delivery device 100 is advancedthrough the drill guide 428 until the outer tubular member 430 is pastthe cortical layer of bone 424 and into the cancellous layer 426 and thedistal edge 432 of the tubular member 420 is aligned with or past thebottom of the cortical layer 424, as shown in FIG. 14B. The button 124is then depressed to allow the trigger 116 to be pulled towards theproximal end 132 of the handle 128, as shown in FIG. 11B, pulling theouter tubular member 430 and the suture 404 back. The flexible fixationmember 402 is larger than the distal tip 432 of the tubular member 420.When the trigger 116 is fully retracted, the flexible fixation member402 is bunched such that it will not pull out of the hole 422 drilled inthe bone. The suture 404 can then be uncleated from the retention member152.

FIGS. 15A-15C show another implementation of the delivery device. Inthis implementation, the tubular member has been omitted. The method issimilar to the method described above with respect to FIGS. 11A-12C. Thedelivery device 100 is loaded with a flexible fixation member 502 andsuture 504 assembly (FIG. 10). The suture 504 is routed through thedelivery device 100 as described above, and then secured in retentionmember 152. The cover 126 hides the suture 504 that is secured in theretention member 152. A hole 506 is drilled in through the corticallayer 508 and into the cancellous layer 510 of bone using a drill guide512. The distal end of the delivery device 100 is advanced through thedrill guide 512 until the forked distal end 514 of the elongatedinserter 516 pushes the flexible fixation member 502 and suture 504assembly past the cortical layer of bone 508 and into the cancellouslayer 510, as shown in FIG. 15B. The button 124 is then depressed toallow the trigger 116 to be pulled towards the proximal end 132 of thehandle 128 (FIG. 11B), pulling the elongated inserter 516 and the suture504 back. As the elongated inserter 516 and the suture 504 are drawnback, the flexible fixation member 502 begins to bunch against thecortical layer 508 of bone. When the trigger 116 is fully retracted, theflexible fixation member 502 is bunched such that it will not pull outof the hole 506 drilled in the bone. The suture 504 can then beuncleated from the retention member 152.

FIGS. 16A-16F show another implementation of the delivery device 600. Aguide 604 includes a distal end portion 602 that is angled relative to alongitudinal axis L of the guide 604, which allows the surgeon toachieve the ideal insertion angle of, for example, a flexible drill,such as the Flexible Twist Drill for 2.3 Osteoraptor™ Curved Guide,available from Smith & Nephew, Inc. of Andover Mass., and/or a flexiblesuture inserter at a quicker rate, thereby reducing the potential ofdamage to cartilage and other tissue within the joint area. The distalend portion 602 of the guide 604 defines an opening 606 which isnarrowed down via a cut or bushing 607 or swaged structure 607 a placedin the distal end portion 602 (FIG. 16C, 16F) relative to the remainderof the cannula 609 of the guide 604. This narrowed portion aids instabilizing and centering a flexible drill bit 900, 901 or a flexibleinserter 902, 903 as it exits the guide 604 through the opening 606,605, as shown in FIGS. 20A, 20B, and 20C. The distal end portion 602also includes one or more holes 608. The holes 608 are used duringsurgery to view the tissue anchor and, specifically the orientation ofthe tissue anchor, prior to inserting the anchor into tissue, such asbone. The holes 608 may also be used to vent bone and other debris thatmay become located within the distal end portion 602 of the guide 604during surgery. The distal end portion 602 of the guide 604 alsoincludes a serrated edge 610, 611 for facilitating maintenance of theguide 604 on the bone during surgery, thereby substantially reducingslippage of the guide 604 off of the bone. Rather than a serrated edge610, 611, the edge 610, 611 may have other features known to one ofskill that would help in maintaining the guide 604 on the bone andreduce slippage. The curved guide 604 is further described in WO2012/048050, which is incorporated herein by reference in its entirety.

FIGS. 17A through 17E illustrate exemplary implementations of a flexibleelongated inserter 612, 614, 613, 615, 662, respectively, that may beused in conjunction with the guide 604 for delivering anchors, such asthe suture anchors described above, into tissue. The flexible elongatedinserters 612, 614, 613, 615, 662 each include an outer tubular member616, 618, 617, 619, 664, which includes at least a flexible portion 620,622, 621, 623, 666 and a rigid, thinned portion 624, 626, 625, 627, 668extending to a distal end 628, 630, 629, 631, 670 of the respectiveinserters 612, 614, 613, 615, 662. The flexible portion 620, 622, 621,623, 666 permits the inserter 612, 614, 613, 615, 662 to substantiallyconform to the shape of the guide 604 when the inserter 612, 614, 613,615, 662 is moved through the cannula 607 or 607 a of the guide 604. Theflexible portion 620, 622, 621, 623, 666 may be made of a flexiblematerial, such as, for example, nitinol or flexible plastics, or may bemade from a coil cut tube (FIG. 17A), or a collection of engagingelements forming a puzzle cut tube (FIG. 17B), or a spring (FIG. 17C),or biocompatible flexible materials tube such as PEEK (FIG. 17E), orwith alternating slits (N degree alternation, N=90 or 180 or otherangles) (FIG. 17E), or other designs known in the art. The distal end628, 630, 629, 631 of each of the inserters 612, 614, 613, 615 includesa pronged-end 632, 634, 633, 635, which receives a portion of a suture650 (FIG. 17B), 651 (FIG. 17C), 652 (FIG. 17E) and a suture anchor 653(FIG. 17C), 654 (FIG. 17D) as described above. The distal end 670 ofinserter 662 may also include a pronged-end (not shown) which receives aportion of a suture and a suture anchor as described above.

Referring to FIG. 18A, the repair suture 650 may be routed through aportion of the rigid portion 626 of the outer tubular member 618 for acertain distance, and then exit the outer tubular member 618 at a pointalong the rigid portion 626 or flexible portion 620. Upon exit from theouter tubular member 618, the suture 650 is then routed proximally alongthe outside of the outer tubular member 618 and between the guide 604.This helps protect the suture from damage during use. In thealternative, as shown in FIG. 18B, the repair suture 650 may be routedproximally within the outer tubular member 618. The same suture routingmethod is applicable to all the inserter options shown in FIG. 17.

The method of use of delivery device 600 is similar to the methoddescribed above with respect to FIGS. 11A-12C. The curved guide 604 isplaced against the cortical layer of tissue. The flexible drill 900 isdelivered through the curved guide 604 and used to form a hole in thebone below the cortical layer. Once the hole is formed, the flexibledrill 900 is removed from the guide 604 and the flexible inserter 902 isinserted through the guide 604. As described above, the repair sutureand suture anchor are preloaded onto the forked end of the flexibleinserter 902. The flexible inserter 902 is advanced through the guide604 past the cortical layer of bone and into the cancellous layer. Theflexible elongated inserter 902 is then retracted and the suture anchoris bunched such that it will not pull out of the hole drilled in thebone, as described with respect to FIGS. 11A-12C.

As discussed above, the distal end portion 602 of the guide 604 definesan opening 606 which narrows down via a cut or bushing 607 placed in thedistal end portion 602 (FIG. 16C) relative to the remainder of thecannula 609 of the guide 604. This narrowed portion aids in stabilizingand centering a flexible drill bit 900 or a flexible inserter 902 as itexits the guide 604. FIGS. 19A-19C illustrate additional implementationsfor assisting in the centering of the drill bit or inserter trajectoryfrom the guide 604. As shown in FIG. 19A, a flexible drill or inserter702 is inserted within a curved guide 704. The curved guide 704 has afirst inner diameter (ID) 706, which is concentric with a first outerdiameter (OD) 708 as taken along line A-A of FIG. 19A. The guide 704 hasa second ID 710, which is concentric with a second OD 712 as taken alongline B-B of FIG. 19A. In this implementation, the longitudinal axis L′of the drill or inserter 702 may be angularly offset from thelongitudinal axis L of the distal end 714 of the curved guide 704because the drill or inserter 702 tends to remain straight.

FIGS. 19B and 19C show implementations of angled guides 716, 718 thataid in aligning the longitudinal axes L, L′ of the flexible drill orinserter 702 and the guide 716, 718. FIG. 19B shows a guide 716 with afirst ID 720, which is concentric with a first OD 722 as taken alongline A-A of FIG. 19B, and a second ID 724, which is eccentric withrespect to a second OD 726 taken along line B-B of FIG. 19B. The secondID 724 is offset toward the inside of the guide 716. The offset secondID 724 brings the longitudinal axis L′ of the distal end of the drill orinserter 702 into substantial angular alignment with the longitudinalaxis L of the distal end of the guide 716. FIG. 19C shows a guide 718with a first ID 728, which is eccentric with respect to a first OD 730as taken along line A-A of FIG. 19C, and a second ID 732, which isconcentric with a second OD 734 taken along line B-B of FIG. 19C. Thefirst ID 728 is offset toward the outside of the guide 718. The offsetfirst ID 728 brings the longitudinal axis L′ of the distal end of thedrill or inserter 702 into alignment with the longitudinal axis L of thedistal end of the guide 718. In addition to aligning the longitudinalaxes L, L′, the offset IDs and ODs may allow the device to supporthigher loads. For example, when bent, the concave side of the bent drillor inserter 702 supports the compressive or tensional loads. Thus, bythickening the wall of the concave side, more load may be supported.

The embodiments of FIGS. 19A-19C, illustrating additionalimplementations for assisting in the centering of the drill bit orinserter trajectory from the guide 604, may also be combined withembodiments of the cut/bushing 607 or swaged structure 607 a illustratedin FIGS. 16A-16F.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made without departingfrom the spirit and scope of the disclosure. For example, the fixationmembers and the flexible members may include a growth factor, such as,for example, an angiogenic factor. The fixation members and the flexiblemembers may also be loaded with a bioactive material, a stimulant, orany substance that promotes healing of the tissue. In addition, thehandle may include more than one cut out portion to allow the trigger tobe secured at different places along the body of the handle. Moreover,the hollow cavity of the cover element may have more than two straightportions, one straight portion, or no straight portions. Elements 146and 148 have been described as slots, but may be through holes or othershapes.

In addition, although the elongated inserter has been described ashaving a rectangular profile at its distal end and a circular profile atits proximal end, other profile combinations, as well as constantprofiles are contemplated.

Moreover, in addition to the particular materials described, theelements of the delivery device may be made from other suitablematerials. For example, the handle may be injection molded and made ofpolycarbonate. Accordingly, other implementations are within the scopeof the following claims.

What is claimed is:
 1. An assembly comprising: a flexible fixationmember comprising a body having two terminal ends; a suture passingthrough the flexible fixation member at various points along a length ofthe body between the terminal ends such that portions of the fixationmember are slidable relative to the suture and configurable to form acluster within a surgical site; and a delivery device comprising: atubular member; an elongated inserter slidably disposed within thetubular member, the inserter comprising a forked distal end and aproximal end, the forked distal end configured to receive a portion ofthe flexible fixation member and the suture therein; and afinger-engageable trigger fixedly coupled to the proximal end of theinserter and configured to advance and retract the inserter relative tothe tubular member, the trigger comprising a retention member forretaining a proximal end portion of the suture.
 2. The assembly of claim1, wherein the delivery device further comprises a handle to which thetrigger is slidably coupled.
 3. The assembly of claim 2, wherein thedelivery device further comprises a button coupled to the trigger andthe handle and configured to permit the trigger to slide relative to thehandle when the button is depressed.
 4. The assembly of claim 3, whereinthe handle defines a plurality of cutout portions along a length of thehandle, the cutout portions configured to receive a portion of thebutton therein to fixedly engage the trigger to the handle.
 5. Theassembly of claim 1, wherein the trigger further comprises acircumferential groove defined about a periphery of the trigger.
 6. Theassembly of claim 5, wherein a length of the suture is wrapped abouttrigger at least once and is retained in the groove.
 7. The assembly ofclaim 5, wherein the trigger further defines a slot configured toreceive a portion of the suture therethrough and direct the suture intothe groove.
 8. The assembly of claim 1, wherein the trigger comprises asubstantially cylindrical body and a pair of finger-engageable elementsextending laterally from the body.
 9. The assembly of claim 1, furthercomprising a cover disposed over the retention member.
 10. The assemblyof claim 2, wherein the handle defines two openings in a distal end ofthe handle, a first opening positioned distally with respect to a secondopening, wherein the suture passes from an interior to an exterior ofthe handle through the first of the two openings and the suture passesfrom the exterior to the interior of the handle through the second ofthe two openings.
 11. The assembly of claim 2, wherein the handledefines two openings in a distal end of the handle, a first openingpositioned distally with respect to a second opening, wherein the suturepasses from an interior to an exterior of the handle through the secondof the two openings and the suture passes from the exterior to theinterior of the handle through the first of the two openings.
 12. Theassembly of claim 2, wherein the handle defines an opening in a distalend of the handle, wherein the suture passes from an interior to anexterior of the handle through the opening.
 13. The assembly of claim 2,further comprising a cover element releasably coupled to a distal end ofthe handle and fixed coupled to a proximal end of the tubular member.14. The assembly of claim 1, wherein the suture passes through thefixation member to form two substantially parallel tail sections ofsuture.
 15. The assembly of claim 1, wherein the fixation member isnon-tubular.
 16. The apparatus of claim 1, wherein the flexible fixationmember and the suture comprise a size 2 suture.
 17. A method of closinga tissue wound, comprising: delivering a wound closure assembly to asurgical site, the wound closure assembly comprising: a flexiblefixation member comprising a body having two terminal ends; a suturepassing through the flexible fixation member at various points along alength of the body between the terminal ends such that portions of thefixation member are slidable relative to the suture and configurable toform a cluster within a surgical site; and a delivery device comprisinga tubular member, an elongated inserter slidably disposed within thetubular member, the inserter comprising a forked distal end, the forkeddistal end configured to receive a portion of the flexible fixationmember and the suture therein, and a finger-engagable trigger fixedlycoupled to the proximal end of the inserter and configured to advanceand retract the inserter relative to the tubular member, the triggercomprising a retention member for retaining a proximal end portion ofthe suture; advancing the inserter distally relative to the tubularmember to position the flexible fixation member within a targeted tissuesite; tensioning the suture to form a cluster of the portions of thefixation member within the surgical site; and retracting the inserterproximally relative to the tubular member to remove the forked distalend of the inserter from within the targeted tissue site.
 18. The methodof claim 17, wherein tensioning the suture to form the cluster of theportions of the fixation member with the surgical site comprises pullingthe fixation member against a distal end of the tubular member.
 19. Themethod of claim 17, wherein tensioning the suture is carried out bymoving the trigger in a proximal direction relative to the tubularmember.
 20. The method of claim 17, wherein retracting the inserter iscarried out by moving the trigger in a proximal direction relative tothe tubular member.
 21. The method of claim 17, wherein tensioning thesuture and retracting the inserter are carried out by moving the triggerin a proximal direction relative to the tubular member such that theforked end of the inserter is moved proximally over a distance beforetensioning of the suture begins.
 22. The method of claim 17, furthercomprising drilling a hole into the tissue.